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The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use.
Pean E, Demolis P, Moreau A, Hemmings RJ, O'Connor D, Brown D, Shepard T, Abadie E, Pignatti F. Pean E, et al. Oncologist. 2012;17(4):543-9. doi: 10.1634/theoncologist.2011-0364. Epub 2012 Apr 3. Oncologist. 2012. PMID: 22477727 Free PMC article. Review.
The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for medicinal products for human use.
Gravanis I, Lopez AS, Hemmings RJ, Jiménez JC, Garcia-Carbonero R, Gallego IG, Giménez EV, O'Connor D, Giuliani R, Salmonson T, Pignatti F. Gravanis I, et al. Oncologist. 2013;18(9):1032-42. doi: 10.1634/theoncologist.2013-0092. Epub 2013 Aug 21. Oncologist. 2013. PMID: 23966222 Free PMC article.
Use of biomarkers in the context of orphan medicines designation in the European Union.
Tsigkos S, Llinares J, Mariz S, Aarum S, Fregonese L, Dembowska-Baginska B, Elbers R, Evers P, Foltanova T, Lhoir A, Corrêa-Nunes A, O'Connor D, Voordouw A, Westermark K, Sepodes B. Tsigkos S, et al. Orphanet J Rare Dis. 2014 Jan 27;9:13. doi: 10.1186/1750-1172-9-13. Orphanet J Rare Dis. 2014. PMID: 24461084 Free PMC article.
Early market access of cancer drugs in the EU.
Martinalbo J, Bowen D, Camarero J, Chapelin M, Démolis P, Foggi P, Jonsson B, Llinares J, Moreau A, O'Connor D, Oliveira J, Vamvakas S, Pignatti F. Martinalbo J, et al. Ann Oncol. 2016 Jan;27(1):96-105. doi: 10.1093/annonc/mdv506. Epub 2015 Oct 20. Ann Oncol. 2016. PMID: 26487583 Free article. Review.
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium. Pe M, et al. Lancet Oncol. 2023 Jun;24(6):e270-e283. doi: 10.1016/S1470-2045(23)00157-2. Lancet Oncol. 2023. PMID: 37269858 Free article. Review.
Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Kluetz PG, et al. Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7. Value Health. 2018. PMID: 29909880 Free article.
Changing views on adverse event reporting.
Flores B, Klaar S, O'Connor DJ. Flores B, et al. Lancet Haematol. 2018 Nov;5(11):e506-e507. doi: 10.1016/S2352-3026(18)30074-7. Epub 2018 Jun 12. Lancet Haematol. 2018. PMID: 29907550 No abstract available.
Improving attribution of adverse events in oncology clinical trials.
George GC, Barata PC, Campbell A, Chen A, Cortes JE, Hyman DM, Jones L, Karagiannis T, Klaar S, Le-Rademacher JG, LoRusso P, Mandrekar SJ, Merino DM, Minasian LM, Mitchell SA, Montez S, O'Connor DJ, Pettit S, Silk E, Sloan JA, Stewart M, Takimoto CH, Wong GY, Yap TA, Cleeland CS, Hong DS. George GC, et al. Cancer Treat Rev. 2019 Jun;76:33-40. doi: 10.1016/j.ctrv.2019.04.004. Epub 2019 Apr 25. Cancer Treat Rev. 2019. PMID: 31108240 Review.
Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.
Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Coens C; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium. Bottomley A, et al. Lancet Oncol. 2016 Nov;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. Epub 2016 Oct 18. Lancet Oncol. 2016. PMID: 27769798 Free article. Review.
2,715 results